http://www.fda.gov/cber/whatsnew.htm Documents recently posted on the CBER Web Site en-us Webmaster@cber.fda.gov Tue, 22 July 2008 08:01:16 EST Tue, 22 July 2008 08:01:16 EST http://www.fda.gov/cber/scireg.htm Animal Models for the Treatment of Acute Radiation Syndrome Tue, 22 July 2008 08:01:16 EST http://www.fda.gov/cber/inside/vacancy.htm#fellowship The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Mon, 21 July 2008 16:40:00 EST http://www.fda.gov/cber/products/fluzone.htm Influenza Virus Vaccine (Fluzone) Mon, 21 July 2008 16:40:00 EST http://www.fda.gov/cber/scireg.htm Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products Mon, 21 July 2008 15:30:16 EST http://www.fda.gov/cber/products/flumist.htm Influenza Virus Vaccine Live, Intranasal (FluMist) Mon, 21 July 2008 14:45:16 EST http://www.fda.gov/cber/products/pentacel/pentacelpack.htm Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Pentacel) Fri, 18 July 2008 12:45:16 EST http://www.fda.gov/cber/flu/flu.htm#tool Influenza is a contagious respiratory illness that can be easily spread through person to person contact. Influenza can cause mild to severe illness and in some cases may lead to death. Thu, 17 July 2008 16:18:00 EST http://www.fda.gov/cber/recalls/sunbbmod062408.htm Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. Thu, 17 July 2008 15:44:00 EST http://www.fda.gov/cber/guidelines.htm#immuno Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency Thu, 17 July 2008 11:04:54 EST http://www.fda.gov/cber/adpromo/benwye063008.htm Wyeth Pharmaceuticals, Inc Thu, 17 July 2008 11:04:54 EST http://www.fda.gov/cber/inside/vacancy.htm#0110 Public Health Analyst, OCTMA Wed, 16 July 2008 08:34:23 EST http://www.fda.gov/cber/rules.htm#08 The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. Tue, 15, July 2008 16:18:02 EST http://www.fda.gov/cber/guidelines.htm#ph1 CGMP for Phase 1 Investigational Drugs Tue, 15, July 2008 16:18:02 EST http://www.fda.gov/cber/inside/vacancy.htm#0111 Program Analyst, PSB/DPS/OM Tue, 15 July 2008 08:13:30 EST http://www.fda.gov/cber/meetings/cpi091508.htm DIA/FDA Critical Path Initiative (CPI) on the Move conference Fri, 11 July 2008 13:10:00 EST http://www.fda.gov/cber/rules.htm#08 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications Fri, 11 July 2008 13:10:00 EST http://www.fda.gov/cber/products/pentacel.htm Summary Basis of Regulatory Action Thu, 10 July 2008 09:40:00 EST http://www.fda.gov/cber/inside/vacancy.htm#0087 Regulatory Information Specialist, ADRM/OD Thu, 10 July 2008 09:40:00 EST